# Spinefrontier, Inc.

- Location (FDA's records): Beverly, MA
- FDA decisions: 24 (2007–2020): 24 510(k) clearances
- Product codes: MAX (6), ODP (4), KWQ (3), OVE (3), MNH (3), OUR (1), KWP (1), MRW (1), MNI (1), NQW (1)
- Predicates its devices cite: 61 (21 its own); citations of its devices by later devices: 55 (21 its own)
- Recalls linked to its devices: 22 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Synthes (Usa): 4 (https://510kreport.com/company/synthes-usa)
- Nuvasive, Inc.: 4 (https://510kreport.com/company/nuvasive)
- Synthes Spine: 4 (https://510kreport.com/company/synthes-spine)
- Eminent Spine: 4 (https://510kreport.com/company/eminent-spine)
- Depuy Spine, Inc.: 3 (https://510kreport.com/company/depuy-spine)
- Medtronic Sofamor Danek: 3 (https://510kreport.com/company/medtronic-sofamor-danek)
- Ldr Spine USA: 2 (https://510kreport.com/company/ldr-spine-usa)
- Buckman Co., Inc.: 2 (https://510kreport.com/company/buckman)

## Firms that cite its devices most
- Lesspine Innovations: 4 (https://510kreport.com/company/lesspine-innovations)
- X-Spine Systems, Inc.: 2 (https://510kreport.com/company/x-spine-systems)
- Alphatec Spine, Inc.: 2 (https://510kreport.com/company/alphatec-spine)
- Choicespine, LP: 2 (https://510kreport.com/company/choicespine)
- Astura Medical: 1 (https://510kreport.com/company/astura-medical)
- Ht Medical D.B.A. Xenix Medical: 1 (https://510kreport.com/company/ht-medical-dba-xenix-medical)
- K2m, Inc.: 1 (https://510kreport.com/company/k2m)
- SurGenTec, LLC: 1 (https://510kreport.com/company/surgentec)

## Its most-cited devices
- K071420: Chameleon Fixation System (2008), cited by 11
- K142026: Spinefrontier Arena-C HA Peek Cervical Intervertebral Body Fusion Device (2014), cited by 7
- K092420: KRD1 Pedicle Screw System (2009), cited by 5
- K150017: SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System (2015), cited by 4
- K121060: Spine Frontier Indus Acp System (2012), cited by 3
- K072289: Spinefrontier Dorado VBR (2007), cited by 3

## Recent decisions
- K193106: SpineFrontier Lumbar Interbody Fusion Device System (Jun 19, 2020)
- K172484: A-CIFT SoloFuse (May 8, 2018)
- K151198: A-CIFT SoloFuse (Jul 17, 2015)
- K142504: SpineFrontier Lumbar Interbody Fusion Device System (May 13, 2015)
- K150017: SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System (Apr 24, 2015)
- K143377: PedFuse Pedicle Screw System (Feb 12, 2015)
- K141333: Arena-C  Tifuse Cervical Intervertebral Body Fusion Device (Nov 25, 2014)
- K142026: Spinefrontier Arena-C HA Peek Cervical Intervertebral Body Fusion Device (Oct 20, 2014)

Source page: https://510kreport.com/company/spinefrontier